Nulojix (belatacept) is an immunosuppressant that works to prevent your body from rejecting a transplanted organ. This monthly infusion through the vein is FDA approved for adults who've had a kidney transplant only. Nulojix (belatacept) is typically given by a trained healthcare professional in a healthcare setting. Side effects can include anemia; swelling in the arms, legs, or feet; and changes in blood pressure. Nulojix (belatacept) is typically taken with other transplant medications to prevent organ rejection.
Nulojix (belatacept) is a type of immunosuppressant called a selective T-cell costimulation blocker. It attaches to two spots on the surface of certain immune cells in your body. The medication stops T-cells from becoming active, recognizing your transplanted kidney as foreign, and attacking it. This helps prevent organ rejection.
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Contact your healthcare provider immediately if you experience any of the following.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
Abdominal or stomach pain
agitation
black, tarry stools
bladder pain
bloating or swelling of the face, arms, hands, lower legs, or feet
bloody or cloudy urine
blurred vision
bone pain
burning while urinating
chills
coma
confusion
convulsions
cough or hoarseness
decreased frequency or amount of urine
decreased urine output
difficult or labored breathing
difficult, burning, or painful urination
dizziness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
fainting
fast or irregular heartbeat
frequent urge to urinate
headache
hostility
inability to move the arms and legs
increased blood pressure
increased thirst
irritability
itching in other skin areas
lethargy
loss of appetite
loss of bladder control
lower back or side pain
mood or mental changes
muscle pain or cramps
muscle spasms (tetany) or twitching
nausea or vomiting
nervousness
numbness or tingling in the hands, feet, or lips
pale skin
pounding in the ears
rapid weight gain
scaling
shortness of breath
slow or fast heartbeat
sores, ulcers, or white spots on the lips or in the mouth
stupor
sudden decrease in the amount of urine
sudden numbness and weakness in the arms and legs
sweating
swelling of the face, ankles, or hands
swollen glands
tightness in the chest
trembling
troubled breathing
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
unusual weight gain or loss
weakness or heaviness of the legs
Less common
Back pain
coughing or spitting up blood
drowsiness
joint pain, stiffness, or swelling
loss of appetite
night sweats
persistent non-healing sore
pink growth reddish patch or irritated area
shiny bump
sudden high fever or low-grade fever for months
swelling of the feet or lower legs
white, yellow, or waxy scar-like area
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Abdominal or stomach cramps
blemishes on the skin
body aches or pain
collection of blood under the skin
cough producing mucus
deep, dark purple bruise
difficulty having a bowel movement (stool)
difficulty with moving
ear congestion
flushed, dry skin
fruit-like breath odor
hair loss or thinning of the hair
increased hunger
increased sweating
increased urination
itching, pain, redness, or swelling
loss of consciousness
loss of voice
muscle cramps in the hands, arms, feet, legs, or face
muscle or bone pain
muscle pain or stiffness
numbness and tingling around the mouth, fingertips, or feet
pain in the joints
shakiness in the legs, arms, hands, or feet
shortness of breath
swelling or inflammation of the mouth
tightness in the chest
trouble sleeping
unable to sleep
unexplained weight loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Nulojix (belatacept) was approved by the FDA in 2011. It's approved for preventing organ rejection in adults who've received a kidney transplant.
Nulojix (belatacept) affects how immune cells called T-cells work in the body. This medication stops T-cells from becoming active and recognizing your newly transplanted kidney as foreign. In turn, it stops the T-cells from attacking your transplanted kidney to help prevent organ rejection. Nulojix (belatacept) can also lower the number of red blood cells in the body and cause anemia as a side effect for some people.
The Nulojix (belatacept) infusion itself takes about half an hour. But also make sure to add some extra time just in case you need to fill out any forms at the medical center. After your first infusion, your transplant specialist or the healthcare professionals at the center might want you to stay for a little while longer. This is just to make sure you tolerate the medication and don't have a reaction to it.
Although it isn't common, some people who've taken Nulojix (belatacept) have reported hair loss. In a couple of clinical studies, less than 10% of people who took the medication noticed hair loss over the span of 3 years. Talk with a healthcare professional if you experience hair loss while you're taking Nulojix (belatacept). They can help figure out what's causing your hair loss.
Weight gain wasn't a side effect that people who received Nulojix (belatacept) reported during clinical studies. Let your transplant specialist know if you gain a large amount of weight. Since your dose of Nulojix (belatacept) is based on your weight, it's important for your prescriber to know about changes in weight. It's possible that your prescriber might need to adjust your dose based on your weight change.
Maybe. Most people receive their Nulojix (belatacept) infusion at a healthcare setting, like an infusion center. But some people have gotten their infusion at home. For these home infusions, the transplant specialist arranges for a nurse to come to your house to administer the medication. Speak with your transplant specialist about whether home infusions of Nulojix (belatacept) are possible for you.
You'll need to get tested for Epstein-Barr virus (EBV) before you start Nulojix (belatacept) because it decides whether you can take the medication or not. Clinical studies suggest that people taking Nulojix (belatacept) who've never been exposed to EBV in the past are at higher risk for post-transplant lymphoproliferative disorder (PTLD) than those who've been exposed to the virus. PTLD is a serious complication that can happen even years after your transplant. People who've never been exposed to EBV (i.e., test negative for EBV) can't take Nulojix (belatacept) because of the high risk for PTLD. Talk to your transplant specialist if you have questions about EBV testing.
Nulojix (belatacept) is FDA approved only for people who've had a kidney transplant. It's not recommended for people with a liver transplant. They have a higher risk that the liver stops working and a higher risk of death. For people who've had a lung transplant, a small study showed that Nulojix (belatacept) might be helpful after trying other medications like tacrolimus (Prograf). But some people still had poor results. And some people who've had a heart transplant took Nulojix (belatacept) to avoid kidney damage that's possible with other transplant medications. These uses are off-label since Nulojix (belatacept) isn't FDA approved for people with lung or heart transplants. Talk to your transplant specialist if you've had a liver, lung, or heart transplant.
Nulojix (belatacept) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
An experienced transplant specialist will manage your treatment with Nulojix (belatacept). This is important because the medication weakens the immune system and puts you at risk for many serious complications. The care team will have the appropriate resources available to make sure your treatment is going well and is safe for you.
People treated with Nulojix (belatacept) have a greater risk for developing post-transplant lymphoproliferative disorder (PTLD) than those treated with cyclosporine. PTLD is a serious condition that can happen after your transplantation. It happens when your white blood cells multiply abnormally, which can potentially lead to lymphoma (a type of blood cancer).
The risk for PTLD is even higher for people who don't have antibodies to Epstein-Barr virus (EBV) and for people who have a cytomegalovirus (CMV) infection. You're also at higher risk if you're receiving T cell-depleting therapies in the hospital to treat rejection.
Contact your transplant specialist if you have fever, night sweats, unplanned weight loss, lower appetite, or changes in vision. Also let them know if you feel a swollen lymph node in the neck, armpit, or groin. Call your transplant specialist right away if you or your loved ones notice unusual changes in mood or behavior, confusion, or problems thinking. These all can be signs of PTLD.
People who take immunosuppressants like Nulojix (belatacept) are at higher risk of developing cancers, such as skin cancer. This is because these medications lower the ability of your body to fight cells that become abnormal.
Lower your risk for skin cancer by limiting your exposure to sunlight and ultraviolet (UV) light. Also wear protective clothing and use sunblock when you're outside.
Nulojix (belatacept) weakens your immune system. It can put you at risk of developing serious or life-threatening bacterial, fungal, and viral infections. During treatment, certain infections that you've had in the past, such as tuberculosis (TB), can come back. And sometimes, opportunistic infections (those that usually only cause problems when the immune system is weak) can develop and potentially lead to serious complications.
Before you start Nulojix (belatacept), your transplant specialist will examine you to check for any infections. Let them know if you have a history of frequent infections, infections that keep coming back, or any long-term infections. Your transplant specialist will talk with you about taking additional medications to protect against infection.
In general, avoid getting sick by trying to stay away from people who are ill. Wash your hands often. Call your transplant specialist right away if you develop symptoms of an infection, such as fever, chills, muscle aches, change in appetite, weight loss, vomiting, or pain while urinating.
Nulojix (belatacept) isn't recommended and isn't FDA approved for people who've had a liver transplant. In a clinical study of people who had a liver transplant, those who received Nulojix (belatacept) had a higher risk for graft loss (losing their transplant) and death than those who received tacrolimus (Prograf). Your transplant specialist will discuss with you about safer transplant medications if you had a liver transplant.
Transplant medications like Nulojix (belatacept) can change the way your immune system responds to vaccines. Some vaccines might not work as well to protect you from infection. Avoid getting any live vaccines while you're taking this medication because your risk of getting sick from the vaccine itself is higher.
Always tell your healthcare professional or pharmacist that you're taking an immunosuppressant like Nulojix (belatacept) before you get vaccinated. They can let you know whether the shot you'd like to receive safe for you.
Nulojix (belatacept) is an intravenous (IV) infusion that's given through your vein. It's administered by a trained healthcare professional.
The dose depends on your body weight. In general, you'll follow a dosing schedule that your transplant specialist sets for you. The dosing schedule might look like the following.
Initial phase
Maintenance phase
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Nulojix (belatacept) will not be safe for you to take.